obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Cholesterol Medication Packaging Study

Official Title ICMJE

Evaluate the Efficacy, Perceptions and Cost of an Innovative Cholesterol Packaging

Brief Summary

The purpose of the overall study is to improve medication use rates among veterans by looking at the risk factors of low-density lipoprotein cholesterol (LDL). It will involve patients who have high LDL-C level (<130mg/dl) and /or may have difficulty taking their medications based on how often they refilled their medications in the last 12 months.

The investigators will test an innovative adherence packaging relative to usual care. The primary hypothesis is that veterans who receive the intervention will have greater improvement in their medication adherence as measured by pill refill at 6 and 12 months of follow up as compared to the control group.

Detailed Description

A sample of participants with elevated LDL level >130 mg/dl and/or <80% medication position ratio in the last 12 months (n=250) will be consented. The study sample will consist of both male and female subjects. Research assistants (RA's) will complete a baseline assessment and then randomly allocated participants to one of the following two groups:

MeadWestvaco (MWV) Packaging Intervention. Patients randomized to the intervention group will receive the MWV medication adherence packaging and adherence education (Packaging Education.) at baseline from a research pharmacist. The participant will then receive their prescribed cholesterol medication in the MWV packaging over the next 12 months.

The Education only Group - Patients randomized to the control group will receive educational material about LDL reduction at baseline.

The study includes the following contacts with participants.

Recruitment letter

Telephone screening

Baseline consent and interview - In person for all participants [Only Adherence Packaging Intervention participants will receive baseline discussion and education from the research pharmacist]

[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.

Intervention: Behavioral: packaging

No Intervention: Education Only Group

Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed. The 6-month interval was selected to maintain contact with patients.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Enrolling by invitation

Estimated Enrollment ICMJE

250

Estimated Completion Date

July 2015

Estimated Primary Completion Date

June 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Enrolled in one of three Durham VA Medical Center (DVAMC) Primary Care clinics for at least one year

AT least one visit to a primary care provider at the Raleigh Community Based Outpatient Clinic (CBOC) or DVAMC associated primary care clinics in the previous 12 months

Outpatient diagnostic code for hypercholesterolemia

uncontrolled LDL in the last 12 months and/or poor LDL refill defined as <80% medication adherence in the last 12 months

prescribed whole tablets of simvastatin, rosuvastatin or pravastatin

Exclusion Criteria:

Diagnosis of metastatic cancer.

Active diagnosis of dementia documented in medical record.

Active diagnosis of psychosis documented in medical record with admission with last 30days.